CFSAN/Office of Food Additive Safety

The Food and Drug Administration (FDA) is responding to the notice, dated December 29, 2005, that you submitted on behalf of Pharming Group, N.V. (Pharming) in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on January 6, 2006, filed it on January 12, 2006, and designated it as GRAS Notice No. GRN 000189.

The subject of the notice is lactoferrin (human) purified from bovine milk (hLF-b). The notice informs FDA of the view of Pharming that hLF-b is GRAS, through scientific procedures, for use as an ingredient in a variety of foods at a level of 100 milligrams per serving.

In a letter dated December 4, 2009, you informed us of Pharming's decision to withdraw GRN 000189. Given your letter, we ceased to evaluate Pharming's GRAS notice, effective December 10, 2009, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000189, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.